Description:
The role requires a comprehensive understanding of regulatory requirements, strong technical writing skills, strong project management skills, and the ability to coordinate cross franchise teams to ensure compliance with EUMDR & IVDR.
The Job:
- Develop & manage project plans, time-lines and budgets.
- Co-ordinate with internal and external stakeholders to ensure all milestones are met
- Identify, manage and mitigate project risks and issues.
- Ensure the organisations data submissions to EUDAMED comply with EUMDR requirements.
- Stay updated on regulatory changes and provide guidance on EUDAMED - related compliance matters.
- Collaborate with quality assurance, IT and other relevant departments to ensure seamless integration and operation of EUDAMED processes.
- Develop and deliver change management processes to maintain data integrity
Have You:
- A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 10 years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is preferred.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- This position may require up to 10% travel.